PlainRecalls
FDA Devices Moderate Class II Terminated

cobas¿ Liat¿ Analyzer

Reported: July 27, 2016 Initiated: May 9, 2016 #Z-2216-2016

Product Description

cobas¿ Liat¿ Analyzer

Reason for Recall

Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

Details

Units Affected
2
Distribution
Distributed in NC and WA.
Location
Branchburg, NJ

Frequently Asked Questions

What product was recalled?
cobas¿ Liat¿ Analyzer. Recalled by Roche Molecular Systems, Inc.. Units affected: 2.
Why was this product recalled?
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2216-2016.